Safety and Efficacy of RAD001 + TACE in Localized Unresectable HCC (TRACER)

Novartis

Status and phase: Terminated; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: everolimus; Drug: everolimus placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01379521

CRAD001OHK02

Details and patient eligibility

About

This study will evaluate the role of everolimus in combination with local Transcatheter Arterial Chemoembolization (TACE) procedure in patients with localized unresectable Hepatocellular Carcinoma (HCC).

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed hepatocellular carcinoma limited to liver and not suitable for resection, liver transplant, or radiofrequency ablation.
• Intermediate stage (stage B) (according to recognized guidelines) and suitable for TACE therapy
• At least one nodule between > 2cm and ≤ 15cm in diameter with no vascular invasion or abdominal lymph node or distant metastases.
• Must have 1 tumor which can be measured in 1 dimension according to specified criteria (RECIST and mRECIST) and has not previously been treated with any type of therapy.
• ECOG performance status < 2cm
• Cirrhotic status of Child-Pugh class A or early B
• HBV-DNA or HBsAg positive at screen or baseline: preventative treatment with anti-viral started 1-2 weeks prior to receiving study drug

Exclusion criteria

• Any local and/or investigational drugs within 28 days prior to randomization
• Active bleeding during the last 28 days prior to screening including variceal bleeding
• Prior therapy with mTOR inhibitors
• Tumor burden of > 60% liver involvement
• Prior systemic or local therapy including TACE except for the first TACE at Day 0), surgery or liver transplantation
• Failed first TACE at Day 0, Cycle 1 for any reason
• Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
• Alcohol intake of 80 grams per day
• Undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from surgery
• Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

everolimus + TACE

Experimental group

Description:

everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)

Treatment:

Drug: everolimus

placebo + TACE

Placebo Comparator group

Description:

Placebo by mouth + transcatheter arterial chemoembolization (TACE)

Treatment:

Drug: everolimus placebo